1. 1
Introduction to Pharmacology

2. Pharmacology Simply defined, from the Greek, as the study of medicine
Pharmacology is an expansive subject encompassing:
How drugs are administered
Where drugs travel in the body
Responses that drugs produce

3. Interrelated Subject Areas
Anatomy and physiology
Chemistry
Microbiology
Pathophysiology

4. Pharmacology Is Challenging and Always Changing
10,000 drugs currently available
Each drug has its own characteristics:
Therapeutic applications
Interactions
Side effects
Mechanisms of action

5. Pharmacology Is Challenging and Always Changing
Many drugs prescribed for more than one disease
Drugs elicit different responses depending on individual factors:
Age
Sex
Body mass
Health status
Genetics

6. Nursing and Pharmocology
Knowledge of pharmacology is essential to the nursing profession.
Nurses are health care providers most often directly involved in patient care.
Applies to nurses in all settings, from hospital to home care
Study of pharmacology is a long, challenging, and continual process.

7. Therapeutics and Pharmacology Are Closely Connected
Therapeutics is concerned with
Prevention of disease
Treatment of suffering
Pharmacotherapy is the application of drugs for
Disease prevention

8. Traditional Drugs Are Chemical Agents
Synthesized in a laboratory
Produce biological responses in the body
If desirable response—therapeutic
If undesirable response—adverse
After a drug is administered, it is called a medication.

9. Biologics
Biologics are agents naturally produced in animal cells, by microorganisms, or by the body itself.

10. Examples of Biologics Hormones Monoclonal antibodies
Natural blood products and components
Interferon
Vaccines

11. Complementary and Alternative Therapies
Natural plant extracts, herbs, vitamins, minerals, dietary supplements
Acupuncture, hypnosis, biofeedback, massage

12. Prescription Drugs and Over the Counter (OTC) Drugs
Prescription drugs require that the recipient obtain a written order from a person with the legal authority to write such a prescription.

13. Advantages and Disadvantages of Prescription Drugs
Health care provider examines the patient and orders the proper drug.
Amount and frequency of drug is controlled.
Instructions on use and side effects of drug are discussed.

14. Advantages and Disadvantages of Prescription Drugs
Require a prescription to obtain
Need for health care provider appointment

15. Advantages and Disadvantages of OTC Drugs
No health care provider appointment required
Often less expensive than prescription drugs

16. Advantages and Disadvantages of OTC Drugs
Patient may choose wrong drug.
Patient may not know reactions or interactions.
Ineffective treatment may result in progression of disease.

17. Early Drug References
The first standard commonly used by pharmacists was the formulary, or list of drugs and drug recipes.
A pharmacopeia is a medical reference summarizing standards of drug purity, strength, and directions for synthesis.

18. United States Pharmacopeia (USP), 1820
First comprehensive publication of drug standards
Summarized standards of drug:
Purity
Strength
Directions for synthesis

19. American Pharmaceutical Organization (APhA)
National professional society of pharmacists, established 1852
Maintained the national compendia of drug standards, the National Formulary (NF)
National Formulary competed with other compendia, U.S. Pharmacopeia (USP).

20. USP and NF Merged in 1975
Formed United States Pharmacopeia–National Formulary (USP-NF)
Official monographs and interim announcements published regularly
Full bound version printed every five years

21. United States Develops and Enforces Tougher Drug Laws, 1900s
Biologics Control Act, 1902
Standardized serum and blood-related products
Pure Food and Drug Act, 1906
Government controls labeling of medicines.
Sherley Amendment, 1912
Prohibited drugs labeled with false therapeutic claims

22. United States Develops and Enforces Tougher Drug Laws, 1900s
Food, Drug, and Cosmetic Act (1938) and amendments
Thorough testing of drug
Proof of safety and efficacy of drug
Dietary Supplement Health and Education Act, 1994
Controls misleading industry claims

23. Figure Medication with the USP label (left) Source: Practice Label “for educational purposes only.”
continued on next slide

24. Figure 1.1 (continued) Medication without USP label (right) Source: Practice Label “for educational purposes only.”

25. Food and Drug Administration (FDA)
Officially established in 1988
Agency of U.S. Department of Health and Human Services in 1988

26. Figure 1.2 A historical time line of regulatory acts, standards, and organizations
continued on next slide

27. Figure 1.2 (continued) A historical time line of regulatory acts, standards, and organizations

28. Center for Drug Evaluation and Research
Branch of FDA
Determines safety and efficacy of drugs
Pharmaceutical laboratories must solicit approval from FDA before marketing a drug.

29. Center for Biologics Evaluation and Research (CBER)
Branch of FDA
Regulates use of biologics (serums, vaccines, and blood products)
1986 Childhood Vaccine Act result of CBER work

30. Center for Food Safety and Applied Nutrition (CFSAN)
Branch of FDA
Oversees herbal and dietary products

31. Center for Food Safety and Applied Nutrition (CFSAN)
Enforces 1994 Dietary and Supplemental Health and Education Act
Regulation not as close as Food, Drug, and Cosmetic Act
Herbal and dietary supplements can be marketed without prior approval from FDA.

32. Four Stages of Approval for Therapeutic and Biologic Drugs
Preclinical investigation
Clinical investigation
Review of new drug application (NDA)
Postmarketing surveillance
Amount of time for approval varies.

33. Figure 1.3 A new drug development time line with the four phases of drug approval

34. Preclinical Investigation
Involves laboratory research
Tests done on cells and animals
Determines drug-dose range
Examines adverse effects
Results considered inconclusive

35. FDA Critical Path Initiative
In 1997, FDA restated its concern that a number of innovative and critical medical products had decreased since the 1990s.
Critical Path Initiative was initiated to modernize the sciences to enhance the use of bioinformation to improve the “safety, effectiveness, and manufacturability of candidate medical products.”

36. Clinical Investigation
Takes place in three different stages termed clinical phase trials
Longest part of approval process
Evaluates human benefits
Tests on healthy humans first, then on those with the target ailment

37. Review of New Drug Application (NDA)
If results of clinical investigation are positive, even if precautions are noted, a New Drug Application is the next step.
NDA is the third step of the drug approval process.
Average review time 17–24 months
Drug approved: process continues
Drug rejected: process suspended

38. Investigational New Drug Application (IND)
May be submitted for Phase I clinical trials when it is determined there are significant therapeutic benefits, and the product is reasonably safe for initial use in humans

39. Postmarketing Surveillance
New drug placed on market
Surveyed for harmful effects in larger population
Diabetes drug troglitazone (Rezulin) is an example of a drug that did not exhibit harmful effects until the year after release.

40. Postmarketing Surveillance
FDA holds annual public meetings.
Will withdraw a drug if serious problem found

41. The Lengthy FDA Drug-Approval Process
NDAs can be massively long and FDA review can take several years.
Pharmaceutical manufacturer expenses for creating and marketing a new drug can be in the millions of dollars.
Core FDA goal is to make sure drugs are safe for the public.

42. Prescription Drug User Fee Act, 1992
Established on five-year trial basis
Drug and biologic manufacturers provide drug-user fee.
FDA hired more employees.
FDA restructured its organization.
Doubled the number of drugs approved
Some review times cut by half

43. Research Shows
Researchers recently completed a review of all adverse drug events reported to the FDA since 2006.
Clinicians found 10 potentially fatal drugs.
Nurses should constantly review the literature for drugs that have been recalled or reported dangerous.

44. Nurses and the Drug Approval Process
Nurses participate most in the drug approval process during the postmarketing surveillance period of Phase IV.
All nurses administering medications monitor for therapeutic effects and adverse reactions from the drugs.
Responsible for reporting adverse reactions